MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body Embolism (4439)

Event Date 12/09/2023

Event Type  Injury  

Event Description

It was reported that bd nexiva, catheter broke and remained in the patient's limb.The following information was provided by the initial reporter: the nurse reports that on december 9, a nexiva 20g catheter was removed due to the presence of phlebitis.There is no report of difficulty in removing the device, but the patient persists with signs of phlebitis at the site of removal of the pivc, in addition to a fever, which is why they request a doppler ultrasound where a foreign body is evident in the area where the removal was performed and according to the report a thrombus is also evident, which is why it is necessary to schedule the removal of the foreign body surgically.The nurse will make an institutional report and will contact bd to inform about the event.Additional information received on 18.Dec.2023: what is the amount affected? a: one (1).What medication was being administered? a: furosemide.Could you provide us with the patient's info? could you please settle any patient impact during or after the surgical procedure to remove the foreign body? a: for now the verbal report of the nurse reporting the adverse event is that the procedure could be carried out without complications.Could you confirm the date the event occurred? a: the event occurred on december 9, was notified via phone call on december 14 and the patient was subjected to the surgical procedure on december 15.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.E1.Address information was not provided, therefore, xx was used as a place holder.

Manufacturer Narrative

Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.

Event Description

No additional information.

• Brand Name: BD NEXIVA
• Type of Device: PERIPHERAL IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18489939
• MDR Text Key: 332602726
• Report Number: 9610847-2023-00369
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: (01)30382903835363
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention